U.S. patent application number 12/562858 was filed with the patent office on 2010-02-25 for fixation of a medical implant to the exterior of a body organ.
This patent application is currently assigned to Medtronic, Inc.. Invention is credited to Martin T. Gerber.
Application Number | 20100049026 12/562858 |
Document ID | / |
Family ID | 36207113 |
Filed Date | 2010-02-25 |
United States Patent
Application |
20100049026 |
Kind Code |
A1 |
Gerber; Martin T. |
February 25, 2010 |
FIXATION OF A MEDICAL IMPLANT TO THE EXTERIOR OF A BODY ORGAN
Abstract
In general, invention is directed to devices for use in surgical
procedures in which a medical implant is affixed to or implanted
within an exterior surface of a body organ. A system, for example,
is described that includes a cannula and a delivery instrument
disposed within the cannula to fix a medical implant to an exterior
surface of an organ. The delivery instrument has a distal end
including a cavity and a vacuum port to draw a portion of the
exterior surface of the organ into the cavity. The medical implant
is affixed to the portion of the exterior surface drawn into the
cavity of the delivery instrument.
Inventors: |
Gerber; Martin T.; (Maple
Grove, MN) |
Correspondence
Address: |
Kent J. Sieffert;SHUMAKER & SIEFFERT, P.A.
Suite 105, 8425 Seasons Parkway
St. Paul
MN
55125
US
|
Assignee: |
Medtronic, Inc.
Minneapolis
MN
|
Family ID: |
36207113 |
Appl. No.: |
12/562858 |
Filed: |
September 18, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10973944 |
Oct 26, 2004 |
7593777 |
|
|
12562858 |
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Current U.S.
Class: |
600/387 ;
600/372 |
Current CPC
Class: |
A61B 5/076 20130101;
A61B 5/14539 20130101; A61B 5/03 20130101; A61N 1/05 20130101 |
Class at
Publication: |
600/387 ;
600/372 |
International
Class: |
A61B 5/04 20060101
A61B005/04 |
Claims
1. A system comprising: an electrode comprising: a conductive
material defining a cavity; and a vacuum inlet that receives vacuum
pressure from a delivery instrument and applies the vacuum pressure
to the cavity to draw tissue from an exterior surface of an organ
of a patient into the cavity.
2. The system of claim 1, wherein the electrode further comprises
an insulative backing coupled to the conductive material.
3. The system of claim 1, further comprising a wireless transceiver
that communicates with an external device.
4. The system of claim 1, further comprising a pulse generator that
delivers electrical stimulation to the conductive material.
5. The system of claim 1, further comprising a lead electrically
coupled to the conductive material.
6. The system of claim 1, further comprising the delivery
instrument, wherein the delivery instrument defines a chamber sized
to hold the electrode, wherein when the electrode is held in the
chamber, the cavity defined by the conductive material is
exposed.
7. The system of claim 1, further comprising a pin that extends
through the conductive material and the cavity to fix the electrode
to the tissue drawn into the cavity.
8. The system of claim 1, wherein the electrode further comprises
an eyelet that receives a securing structure to secure the
electrode to the tissue.
9. The system of claim 1, further comprising: a cannula capable of
being introduced into an abdomen of the patient via an incision in
the abdomen; and wherein the delivery instrument is disposed within
the cannula, the delivery instrument comprising a vacuum outlet
through which the vacuum pressure is applied to the vacuum inlet of
the electrode to draw a portion of the exterior surface of the
organ into the cavity defined by the conductive material.
10. The system of claim 9, further comprising: a source of vacuum
pressure coupled to the delivery instrument; and a conduit through
the delivery instrument to apply the vacuum pressure from the
source to the exterior surface of the organ.
11. The system of claim 9, further comprising a trocar disposed
within the cannula, wherein the delivery instrument is disposed
within the trocar.
12. The system of claim 1, further comprising: means for
introducing a delivery instrument into the patient via an incision
in an abdomen of the patient; and means for applying vacuum
pressure to an exterior surface of an organ to draw at least a
portion of the exterior surface into the cavity defined by the
conductive material.
13. The system of claim 12, further comprising means for affixing
the electrode to the portion of the exterior surface drawn into the
cavity.
14. The system of claim 13, further wherein the means for affixing
the electrode comprises means for anchoring the electrode to the
portion of the exterior surface drawn into the cavity defined by
the conductive material.
Description
[0001] This is a divisional application of U.S. patent application
Ser. No. 10/973,944 filed Oct. 26, 2004. The entire content of this
application is incorporated herein by reference.
TECHNICAL FIELD
[0002] The invention relates generally to surgical techniques, and,
more particularly, to laparoscopic techniques for fixing a medical
implant to an exterior surface of an organ.
BACKGROUND
[0003] A common surgical technique is a laparoscopic procedure in
which, after administering a general anesthetic, a patient's
abdomen is inflated with CO.sub.2 or other inert inflammable gas.
Rigid tubes with air-tight valve mechanisms ("trocars") are then
inserted into the gas-filled abdominal cavity so that a video
camera and other surgical instruments can be introduced into the
abdomen. The video camera is typically deployed via an endoscope
that projects a view of the abdomen onto a video monitor located in
the operating room.
[0004] Laparoscopy surgery is used for a variety of reasons. In
some situations, laparoscopic surgery is used to affix or implant a
miniaturized medical device or circuit, drug bolus or other item or
object on or within the exterior surface of an organ. As one
example, U.S. Pat. No. 6,510,332 to Robert J. Greenstein describes
an electrode which is designed and adapted for application by
laparoscopic surgery. The electrode includes an attachment member
which can be attached to body organs, even in cases where the organ
is subject to vigorous, periodic peristaltic movement within the
body (e.g., digestive organs).
[0005] As another example, U.S. Pat. No. 6,626,919 to Lee L.
Swanstrom describes a laparoscopic technique in which a locking
apparatus is used for securing an implant, such as a stent or stent
graft, to a vessel or organ wall. Other examples include U.S. Pat.
No. 5,766,234 to James C. Chen and U.S. Pat. No. 6,506,190 to
Christopher J. Walshe that describe a flexible probe and a tissue
anchor, respectively, that may be delivered via laparoscopic
procedures. As yet another example, U.S. Pat. No. 5,580,569 to
Vincent C. Giampapa describes a biodegradable therapeutic agent
proportioned for laparoscopic delivery to a tumor or surgical
site.
[0006] Table 1 below lists documents that disclose laparoscopic
techniques and devices for delivery via such techniques.
TABLE-US-00001 TABLE 1 Patent Number Inventors Title 6,510,332
Robert J. Greenstein Obesity treatment tools and methods 6,626,919
Lee L. Swanstrom Method and apparatus for attaching or locking an
implant to an anatomic vessel or hollow organ 6,506,190 Christopher
J. Walshe Tissue anchor system 5,580,569 Vincent C. Giampapa
Article for tissue-specific delivery of therapeutic agents
5,766,234 James C. Chen Implanting and fixing a flexible probe for
administering a medical therapy at a treatment site within a
patient's body
[0007] All documents listed in Table 1 above are hereby
incorporated by reference herein in their respective entireties. As
those of ordinary skill in the art will appreciate readily upon
reading the Summary, Detailed Description and Claims set forth
below, many of the devices and methods disclosed in the patents of
Table 1 may be modified advantageously by using the techniques of
the present invention.
SUMMARY
[0008] The invention is directed to devices and methods for use in
laparoscopic surgical procedures in which a medical implant is
affixed to or implanted within an exterior surface of a body
organ.
[0009] Various embodiments of the present invention provide
solutions to one or more problems existing in the prior art with
respect to laparoscopic delivery devices. The problems include, for
example, inability of the delivery devices to adequately stabilize
the exterior surface tissue of the organ, and inadequate feedback
provided to the physician regarding proper positioning of the
medical implantation to be delivered. These problems, in turn, can
result in improper or insecure placement of an implant within the
patient, undermining the efficacy or longevity of the implant.
[0010] Various embodiments of the present invention are capable of
solving at least one of the foregoing problems. In general, the
invention provides for methods and devices for vacuum-assisted
laparoscopic delivery of the medical implant to the exterior
surface of the body organ. The term "medical implant" is used
herein to refer to any object that may be affixed to or implanted
on an exterior of an organ via a laparoscopic procedure. For
example, the medical implant may be an electrode for electrically
stimulating the surface of the organ. As another example, the
medical implant may comprise a diagnostic sensor or monitoring
circuit for sensing one or more physiological conditions associated
with the organ. The medical implant may also take the form of a
therapeutic drug, an isotope for fixation on or near a cancerous
region of an organ, or other composition that may be implanted via
the laparoscopic procedure. The present invention may be utilized
to laparoscopically deliver a medical implant to the surface of any
of a number of body organs, including a patient's stomach, kidney
or bladder.
[0011] The invention includes embodiments directed to a method
comprising applying vacuum pressure to an exterior surface of an
organ to draw at least a portion of the exterior surface into a
cavity of a laparoscopic delivery instrument, and affix a medical
implant to the portion of the exterior surface drawn into the
cavity. The invention also includes embodiments directed to a
system and a device that can perform laparoscopic delivery of a
medical implant with a vacuum in accordance with the present
invention. A system, for example, is described that includes a
laparoscopic cannula and a delivery instrument disposed within the
cannula to fix a medical implant to an exterior surface of an
organ. The delivery instrument has a distal end including a cavity
and a vacuum port to draw a portion of the exterior surface of the
organ into the cavity. The medical implant is affixed to the
portion of the exterior surface drawn into the cavity of the
delivery instrument. In comparison to known techniques for fixation
of implants to the exterior surface of an organ, various
embodiments of the invention may provide one or more advantages.
For example, various embodiments of the invention. For example, the
application of vacuum pressure may be used to stabilize the
exterior surface of the organ for improved fixation of the medical
implant, e.g., by drawing tissue from the exterior surface into a
chamber to permit attachment of medical implant.
[0012] The above summary is not intended to describe each
embodiment or every embodiment of the present invention or each and
every feature of the invention. Advantages and attainments,
together with a more complete understanding of the invention, will
become apparent and appreciated by referring to the following
detailed description and claims taken in conjunction with the
accompanying drawings.
[0013] The details of one or more embodiments of the invention are
set forth in the accompanying drawings and the description below.
Other features, objects, and advantages of the invention will be
apparent from the description and drawings, and from the
claims.
BRIEF DESCRIPTION OF DRAWINGS
[0014] FIG. 1 is a schematic diagram illustrating a laparoscopic
system for affixing a medical implant to an exterior surface of an
organ.
[0015] FIG. 2 is a schematic diagram illustrating an exemplary
laparoscopic delivery instrument for fixing a medical implant to an
exterior surface of an organ.
[0016] FIGS. 3A-3D are block diagrams illustrating a distal end of
the laparoscopic delivery instrument of FIG. 2 when interacting
with the exterior surface of an organ.
[0017] FIGS. 4A-4B are schematic diagrams illustrating top-views of
embodiments of electrodes suitable for fixation to an exterior
surface of a stomach or other organ.
[0018] FIGS. 5A-5D are schematic diagrams showing another
embodiment of a distal end of a delivery instrument for use in
implant of a capsule within an exterior surface of an organ.
[0019] FIG. 6 is a flow diagram illustrating operation of a
laparoscopic delivery instrument in which a medical implant is
affixed to an exterior surface of an organ.
DETAILED DESCRIPTION
[0020] FIG. 1 is a schematic diagram illustrating a laparoscopic
fixation system 10 for affixing a medial implant 11 to the exterior
surface 13 of a stomach 12. As shown in FIG. 1, the fixation system
10 uses a laparoscopic surgical technique to reach exterior surface
13 of stomach 12. In laparoscopic surgery, the patient receives
general anesthesia and one or more small incisions are made in an
abdomen 9 of the patient, usually via a trocar or other surgical
instrument. Abdomen 9 is inflated with carbon dioxide or other
inert gas from a gas source 15, and a video camera endoscope 17A is
often inserted within the abdomen 9 so a surgeon can see the
abdominal organs as displayed by monitor 17B. There are multiple
targets for fixation of a medical implant to stomach 12 shown in
FIG. 1, including, for example, a greater curvature 16, a lesser
curvature 18, and a vagus nerve 19.
[0021] As shown in FIG. 1, the fixation system 10 includes a
laparoscopic delivery instrument 26 ("delivery instrument 26") to
affix medical implant 11 to exterior surface 13 of stomach 12. As
described herein, delivery instrument 26 applies a vacuum pressure
to exterior surface 13 of stomach 12 to immobilize at least a
portion of the exterior surface. Delivery instrument 26 then
affixes medical implant 11 to the immobilized portion. Fixation of
implant 11 may involve anchoring medical implant 11 to exterior
surface 13 or implanting the implant below the exterior surface.
Vacuum source 20 controls delivery of the vacuum pressure to
delivery instrument 26, which includes tubular member 24 for
conveying the vacuum pressure, and may be any conventional type of
vacuum source suitable for delivering vacuum pressure to a
laparoscopic surgical tool.
[0022] Delivery instrument 26 is inserted into an abdomen 9 of a
patient through a cannula 22 during laparoscopic surgery. In
general, cannula 22 is a flexible over-tube, and may be used with a
trocar to provide an opening into the abdominal cavity of the
patient. In that case, cannula 22 and delivery instrument 26 may be
contained within the trocar, or the trocar may be removed prior to
insertion of the delivery instrument.
[0023] Delivery instrument 26 is sized to fit within stomach 12 of
the patient. Accordingly, cannula 22 is sized to fit within
delivery instrument 26. Delivery instrument 26 may be flexible or
curved to conform to a shape of the stomach at the target region.
As will be described, delivery instrument 26 may comprise any of a
variety of tools that apply vacuum pressure from vacuum source 20,
and utilize the vacuum pressure for stabilization of the exterior
surface of stomach 12 for fixation of medical implant 11, e.g., by
drawing tissue from the exterior surface into a chamber to permit
attachment of medical implant 11.
[0024] Delivery instrument 26 includes a proximal portion having a
handle 21 and flexible tubular member 24 that extends from handle
21 into the body of the patient. Medical implant 11 is coupled to a
distal end of delivery instrument 26 for fixation (i.e., anchorage
or implantation) at a particular location of the exterior of
stomach 12.
[0025] Delivery instrument 26 includes a vacuum inlet 23 on handle
21 to couple delivery instrument 26 to vacuum source 20. A vacuum
outlet (not shown) at the distal end of delivery instrument 26 and,
more particularly, at the interface between the delivery instrument
and medical implant 11, applies the suction from vacuum source 20
to the exterior of the stomach in order to draw tissue into a
chamber within distal end of delivery instrument 26. Distal end of
delivery instrument 26 may apply the vacuum pressure, i.e.,
negative pressure, directly to exterior surface 13 of stomach 12 to
draw the tissue into the chamber. Alternatively, delivery
instrument 26 may apply the vacuum pressure through one or more
voids within medical implant 11, causing the tissue of exterior
surface 13 to draw into the chamber through the medical
implant.
[0026] Delivery instrument 26 affixes medical implant 11 to the
tissue drawn into the chamber, and disengages from medical implant
11, thereby leaving medical implant 11 attached to or implanted
within exterior surface 13 of stomach 12. Delivery instrument 26
may, for example, advance a locking pin through the tissue drawn
into the chamber of delivery instrument 26 to anchor medical
implant 11 to the exterior of stomach 12. Alternatively, delivery
instrument may inject medical implant 11 into the tissue drawn into
the chamber.
[0027] In some embodiments, delivery instrument 26 may detect
pressure variances within a pressure sensitive chamber within
delivery instrument 26 to assist the surgeon in determining whether
medical implant 11 is properly positioned on the exterior surface
13 of stomach 12. The distal end of delivery instrument 26 may, for
example, be formed from a flexible material such that outside
pressure applied to the distal end of the instrument by stomach 12
causes the flexible portion to deform, thereby varying the pressure
within the instrument. Delivery instrument 26 may include a display
31 to output an indication of the pressure experienced by the
distal end of the delivery instrument, thereby providing an
indication of whether medical implant 11 is properly engaged with
exterior surface 13. This indication, along with the a
visualization endoscope, provide guidance to the surgeon for proper
placement of implant 11.
[0028] As described further below, medical implant 11 may be any of
a variety of implantable objects suitable for fixation to the
exterior surface of stomach 12. For example, medical implant 11 may
be an electrode for electrically stimulating the surface of stomach
12. The electrode may be coupled to an elongated lead carrying an
electrical conductor to receive electrical stimulation energy from
an implanted pulse generator designed for gastric stimulation, or
may be self contained to include a pulse generator and a wireless
transceiver for communication of sensed data to an external monitor
or diagnostic device. As another example, medical implant 11 may
comprise a diagnostic sensor or monitoring circuit for sensing one
or more physiological conditions associated with the stomach 12,
such as pressure, pH, temperature, fullness or other conditions. In
some embodiments, implant 11 may be a sensor or strain gauge for
monitoring peristaltic activity. Medical implant 11 may also take
the form of a biologic or a therapeutic drug. The biologic or drug
may be selected to delivery a therapy for a condition, or to
selectively kill diseased or cancerous tissue, e.g., for
chemotherapy. As another example, medical implant 11 may take the
form of a radioactive isotope for fixation on or near a cancerous
region of stomach 12 to support radiation therapy.
[0029] For ease of illustration, the invention is shown in
reference to fixation of medical implant 11 to exterior surface 13
of stomach 12. However, the techniques described herein may be
utilized to affix medical implant 11 to an exterior surface of
other organs, including a bladder, small or large intestines,
kidney or other organ of a body.
[0030] FIG. 2 is a schematic diagram illustrating an exemplary
embodiment of delivery instrument 26 (FIG. 1) in further detail. In
the illustrated embodiment, delivery instrument 26 includes handle
21 and flexible tube member 24 that extends from handle 21. Medical
implant 11 is coupled to a distal end of probe 26 for delivery to
an exterior surface of an organ, such as stomach 12 of FIG. 1.
Specifically, delivery instrument 26 delivers medical implant 11 to
the appropriate location along stomach 12 and anchors or implants
medical implant 11 at the appropriate location.
[0031] In the illustrated example, delivery instrument 26 is
capable of measuring pressure variation within a pressure sensitive
chamber in order to assist the surgeon in laparoscopically fixing
medical implant 11 to the stomach. Specifically, delivery
instrument 26 includes a pressure sensor 38 to detect pressure
variations within a pressure sensitive chamber of delivery
instrument 26. Delivery instrument 26 further includes a display 32
located on handle 21 that displays the pressure measurements made
by pressure sensor 38. As described above, display 32 may display
pressure measurements with varying accuracy depending on the
application. For example, display 32 may display relative pressure
variations, e.g., using a number of LEDs that successively light up
as the pressure increases. Pressure sensor 38 can comprise, for
example, a piezoelectric pressure sensor, a capacitive pressure
sensor, or any other sensor capable of detecting pressure
variations. Handle 21 further incorporates appropriate electronics
(not shown) to process the signals generated by pressure sensor 38
and drive display 32.
[0032] Vacuum inlet 23 receives pressure from vacuum source 20
(FIG. 1), and conveys the vacuum pressure to an inner portion 25 of
delivery instrument 26 to form a pressure sensitive chamber. The
pressure sensitive chamber may be controlled within delivery
instrument 26 by closing a vacuum inlet 23 and covering vacuum
outlet 40 with a membrane 42. Delivery instrument 26 may include a
controller 44 on handle 21 to assist in opening and closing of
vacuum inlet 23 and, thus, application of suction from vacuum inlet
23. Controller 44 may further control the pressure monitoring
capabilities of delivery instrument 26. In particular, controller
44 may be utilized to active and deactivate power pressure sensor
38 and display 32. For example, controller 44 may close vacuum
inlet 23 and activates pressure sensor 38 and display 32 before
probe 26 of delivery instrument 26 is introduced into an abdomen of
a patient through cannula 22 during laparoscopic surgery. In
certain embodiment, controller 44 may comprise a plunger that is
successively pushed through different stages to perform sequential
operations during the delivery of medical implant 11 to the
appropriate location along stomach 12. Alternatively, controller 44
may comprise a dial, switch, or similar control mechanism that can
be switched to different settings to perform different
functions.
[0033] Membrane 42 covering vacuum outlet 40 may be constructed of
a flexible material such as flexible plastic. Membrane 42 can be
adhered over vacuum outlet 40 during manufacture of delivery
instrument 26. Membrane 42 prevents air from escaping via vacuum
outlet 40, in turn, making the pressure sensitive chamber
airtight.
[0034] Membrane 42 within the distal end of probe 26 deforms due to
pressure variations experienced by the exterior surface of stomach
12. For example, when the distal end of probe 26 is being inserted
and forced against the exterior surface, membrane 42 deforms due to
an increased pressure caused by the application force, causing a
pressure variation within the pressure sensitive chamber. Pressure
sensor 38 detects the pressure variation within the pressure
sensitive chamber, i.e., the pressure variation caused by the
deformation of the distal end of probe 26, and delivery instrument
26 conveys the pressure variation via display 32 to a user. In this
manner, delivery instrument 26 provides an indication of the amount
of force applied to the exterior surface of the stomach, thereby
providing an indication of whether medical implant 11 is properly
positioned for fixation to the surface.
[0035] Upon identifying the appropriate location for placement of
medical implant 11, controller 44 opens vacuum inlet 23 and
deactivates, i.e., shuts off, the pressure detection functionality
of delivery instrument 26. Vacuum inlet 23 receives sufficient
suction pressure from vacuum source 20 to cause membrane 42 that
covers vacuum outlet 40 to be removed. In other words, the suction
pressure from vacuum sources 20 opens vacuum outlet 40 by opening,
removing or rupturing membrane 42. Membrane 42 covering vacuum
outlet 40 may be completely removed by the suction pressure. For
example, the suction pressure may have a larger force than the
adhesive holding membrane 42 over vacuum outlet 40. Alternatively,
the suction of the vacuum may, instead, rupture membrane 42 in
order to open vacuum outlet 40.
[0036] Upon removal or rupture of membrane 42, the suction from
vacuum source 20 is further applied to vacuum outlet 40 to draw a
portion of exterior surface 13 of stomach 12 into a void 46 of
medical implant 11. Upon drawing the exterior surface tissue of
stomach 12 into void 46, controller 44 is adjusted to cause
delivery instrument 26 to affix medical implant 11 to the tissue.
For example, controller 44 can be adjusted to cause a shaft 48 to
advance a locking pin (not shown) through the surface tissue within
void 46 in order to anchor medical implant 11 to the exterior of
stomach 12. If controller 44 comprises a plunger, the plunger may
be actuated into handle 21 in order to advance the locking pin
through the tissue. However, any type of anchoring mechanism may be
used to anchor medical implant 11 to the tissue, such as a staples
or sutures. In other embodiments, controller 44 can be adjusted to
affix medical implant 11 to exterior surface 13 of stomach 12 by
partially or entirely implanting the medical implant within the
tissue drawn into void 46. Once medical implant 11 is affixed to
the exterior surface, the medical implant detaches from delivery
instrument 26, thereby leaving the medical implant attached to the
organ, e.g., the stomach.
[0037] FIGS. 3A-3D are block diagrams illustrating side views of
one embodiment of a distal end of delivery instrument 26.
Particularly, FIGS. 3A-3D illustrate the distal end of delivery
instrument 26 in operation to affix a medical implant (i.e., an
electrode 54 having a conductive lead 56, a conductive material 53A
and an insulative backing 53B in this example) to the exterior
surface 13 of the stomach.
[0038] FIG. 3A illustrates the distal end of delivery instrument 26
positioned proximal to exterior surface 13 of stomach 12. In the
illustrated embodiment, the distal end of delivery instrument 26
includes a chamber 32 sized to hold electrode 34. Delivery
instrument 26 further includes membrane 42 covering a vacuum port
40 formed within electrode 34 to provide a pressure sensitive
cavity 46, also referred to as a "void," for use in fixing
electrode 54 to exterior surface 13 of stomach 12.
[0039] Tubular member 24 provides a conduit for conveying a vacuum
pressure created by vacuum source 20 (FIG. 1) to cavity 46. The
vacuum pressure removes or ruptures membrane 42, as shown in FIG.
3B. As a result, delivery instrument 26 draws a portion 47 of the
exterior surface 13 of stomach 12 into cavity 46 of electrode
54.
[0040] FIG. 3C illustrates anchoring of electrode 54 to the
exterior surface 13 of stomach 12 via advancement of a locking pin
60 by shaft 48 through the portion 47 of the surface drawn into
cavity 46 of electrode 54. During this process, the vacuum pressure
maintains the draws tissue into contact with the electrical surface
of electrode 54 to stabilize the tissue and ensure secure
electrical contact. Locking pin 60 may comprise any of a variety of
biocompatible structural materials which are well known in the
medical art, such as stainless steel, titanium, high density
polyethylenes, nylon, PTFE, or other material.
[0041] FIG. 3D illustrates the detachment of electrode 54 from
delivery instrument 26. As illustrated in FIG. 3D, lead 56 remains
coupled to electrode 54 and disposed within delivery instrument 26.
Delivery instrument 26 is withdrawn from the abdominal cavity of
the patient, and lead 56 is then removed from the delivery
instrument and utilized in the desired manner, e.g., to sense
electrical activity or deliver electrical stimulation to the
exterior surface 13 of stomach 12. For example, lead 56 may be
guided or tunneled to a pulse generator, which also is implanted
within the patient. In other embodiments, lead 56 may extend from a
diagnostic sensor to a monitoring device, which is implanted within
or external to the patient.
[0042] FIG. 4A is a schematic diagram illustrating a top-view of an
electrode 54A suitable for fixation to an exterior surface of
stomach 12 or other organ. In the example embodiment of FIG. 4A,
electrode 54A includes an electrically conductive surface 59, a
vacuum port 40 to receive a vacuum pressure and apply the vacuum
pressure to a bottom surface of the electrode, and a conductive
lead 56. As illustrated in FIG. 4A, locking pin 60 remains disposed
within vacuum port 40, thereby anchoring electrode 54A to a portion
of the exterior surface of stomach 12 (not shown) drawn up into
cavity 46 of the electrode.
[0043] FIG. 4B is a schematic diagram illustrating a top-view of
another exemplary electrode 54B suitable for fixation to an
exterior of stomach 12. In certain embodiments, as shown in FIG.
4B, electrode 54B has one or more eyelets 61, which serves to hold
respective suture 62, string, staples, or other securing
structures, which can secure the electrode to exterior surface 13
of stomach 12. Utilization of vacuum pressure to draw tissue into a
cavity of electrode 54B may be advantages to ensure a secure,
stable contact between electrode 54B and the tissue during the
suturing process. A conventional laparoscopic suturing mechanism
may be deployed to secure sutures 62. Many other possible
attachments mechanisms, such as one or more polymeric filament,
surgical adhesive, loops, rings, brackets, tacks, hooks, clips,
strings, threads, or screws, can be utilized to facilitate the
attachment or fixation of electrode 54 to the exterior surface of
the stomach or another organ.
[0044] FIGS. 5A-5D are schematic diagrams showing another
embodiment of a distal end of delivery instrument 26. Specifically,
FIGS. 5A-5D illustrate a vacuum-assisted laparoscopic technique for
implantation of a medical implant, i.e., a capsule 79 in this
example, within an exterior surface of an organ. FIG. 5A depicts
exterior tissue 78 of an organ drawn into a cavity 80 by vacuum
pressure applied via one or more vacuum ports 82. Unlike the
embodiments illustrated in FIGS. 3A-3D, vacuum ports 82 apply
vacuum pressure directly to surface tissue 78 without utilizing a
vacuum port of the medical implant.
[0045] With tissue 78 drawn into cavity 80, a physician manipulates
delivery instrument 26 to form a hole in the tissue with needle 92,
as shown in FIG. 5B. The physician pushes needle 90 through sheath
88, thereby making the hole in the tissue drawn into cavity 80 and
stabilized by vacuum ports 82.
[0046] Insertion of needle 92 through tissue 100 causes needle 92
to form a pocket in the tissue. This pocket, which receives capsule
89, may be enlarged by injection of fluid, such as a saline
solution, into the tissue 102. The physician withdraws needle
assembly 90 from sheath 88, and inserts capsule 79 into sheath 88.
The physician pushes capsule 79 through the hole and into the
pocket in tissue 78 with pushrod assembly 94, as shown in FIG. 5C.
After implanting capsule 79, the physician removes delivery
instrument 26, and the capsule remains embedded within the exterior
surface of the organ.
[0047] In certain embodiments, capsule 79 may comprise a
therapeutic drug for treatment of physical conditions exemplary
classes of drugs include membrane channel drugs, antimuscarinic and
channel blockers, antagonists, alpha adrenoceptor antagonists, beta
adrenoceptor agonists, antidepressants, prostatglandin synthesis
inhibitors, motor neuron suppression drugs, sensory desensitization
drugs, anti-inflammatory drugs, hormones, muscarinic receptor
agonists, anticholinesterase inhibitors, antibiotics, analgesic
drugs, tricyclic antidepressants, muscle relaxants,
anticholinergic, sensory desensitization drugs, anti-diarrheal
drugs, motility inhibition drugs, motility stimulation drugs,
tricyclic antidepressants, enzyme inhibitors, vascular dilators,
smooth muscle relaxants, hormone replacements, selective serotonin
reuptake inhibitors, tricyclic antidepressants and other drugs.
[0048] As another example, a radioactive isotope for implantation
on or near a cancerous region of an organ, a polymer or other
compound or material may be delivered. In some embodiments, capsule
79 may be an expandable hydrogel that expands to a larger sized due
to reyhdration following implantation. Capsule 79 may be
cylindrical, spherical, egg-shaped, or a partial cylinder for
delivery through needle 92.
[0049] FIG. 6 is a flow diagram illustrating operation of delivery
instrument 26 when used during laparoscopic surgery to deliver
medical implant 11 to an exterior surface of an organ, such as
stomach 12. In laparoscopic surgery, the patient receives general
anesthesia and one or more small incisions are made in an abdomen
of the patient. Initially, the abdomen is inflated with carbon
dioxide so a surgeon can see the abdominal organs, and delivery
instrument 26 is inserted within the abdominal cavity (100).
[0050] Next, vacuum source 20 applies vacuum pressure to delivery
instrument 26, which forms a pressure sensitive chamber (102). As
delivery instrument 26 enters the abdominal cavity and is forced
against the exterior of a body organ, e.g., stomach 12, the
pressure applied by the exterior surface deforms the distal end of
the instrument, thereby causing a pressure variation within the
pressure sensitive chamber. Delivery instrument 26 conveys the
pressure variation to the physician via a display 32 to provide an
indication of whether medical implant 11 is properly positioned
against the exterior surface of the organ (104).
[0051] Once positioned, delivery instrument 26 opens vacuum inlet
23, which receives suction pressure from vacuum source 20 (106).
The suction applied via the vacuum causes membrane 42 covering
vacuum outlet 40 to rupture or be completely removed, in turn,
opening vacuum outlet 40 (108). The suction applied by the vacuum
further draws exterior tissue from the organ into a chamber of
delivery instrument 26 (110). In embodiments of the invention, the
exterior tissue may be drawn directly into delivery instrument 26
or through a void within medical implant 11.
[0052] Delivery instrument 26 affixes medical implant 11 to the
drawn tissue using any of a variety of mechanisms (112). For
example, delivering device 22 may advance a locking pin through the
tissue drawn into the void of medical implant 11 to anchor medical
implant 11 to the exterior surface of the organ, or may inject the
medical implant within the tissue. Medical implant 11 is then
detached from delivery instrument 26, thereby leaving medical
implant 11 anchored to the organ (114).
[0053] The preceding specific embodiments are illustrative of the
practice of the invention. It is to be understood, therefore, that
other expedients known to those skilled in the art or disclosed
herein may be employed without departing from the invention or the
scope of the claims. For example, the present invention further
includes within its scope methods of making and using systems as
described herein.
[0054] In the claims, means-plus-function clauses are intended to
cover the structures described herein as performing the recited
function and not only structural equivalents but also equivalent
structures. Thus, although a nail and a screw may not be structural
equivalents in that a nail employs a cylindrical surface to secure
wooden parts together, whereas a screw employs a helical surface,
in the environment of fastening wooden parts a nail and a screw are
equivalent structures.
[0055] Several embodiments of the present invention are described
above. It is to be understood that various modifications may be
made to those embodiments of the present invention without
departing from the scope of the claims. These and other embodiments
are intended to fall within the scope of the appended claims.
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